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In Monday’s session, the share of one of the leaders in branded generics in India moved up by 11.5 percent on BSE to hit an intraday high at Rs. 1,227.35, after the company received final approval from the USFDA for Betamethasone Valerate Foam. 

With a market cap of Rs. 21,935.5 crores, at 11:18 a.m., the shares of Alembic Pharmaceuticals Limited were trading in the green at Rs. 1115.95, up by 1.4 percent, compared to its previous closing price of Rs. 1,100.55. 

What’s the news: 

According to the latest regulatory filings on the stock exchanges, Alembic Pharma announced receiving final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Betamethasone Valerate Foam, 0.12 percent. 

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Luxiq Foam, 0.12 percent, of Norvium Bioscience, LLC (Norvium). 

Betamethasone valerate foam, 0.12 percent, is a medium potency topical corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp. 

Presently, Alembic Pharma has a cumulative total of 213 ANDA approvals (185 final approvals and 28 tentative approvals) from USFDA. 

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Previous News: 

On 13th August, Alembic Pharma received final approval from the USFDA for Dabigatran Etexilate Capsules, 110 mg. 

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pradaxa Capsules, 110 mg of Boehringer Ingelheim Pharmaceuticals, Inc. (Boehringer). 

Dabigatran Etexilate Capsules 110 mg are indicated for prophylaxis of deep vein thrombosis and pulmonary embolism following hip replacement surgery. 

Financials and Future Outlook: 

The company has reported a significant growth in the revenue from operations, with a 5.2 percent YoY rise from Rs. 1,486 crores in Q1 FY24 to Rs. 1,562 crores in Q1 FY25.

Similarly, the net profit jumped by 12 percent YoY from Rs. 121 crores to Rs. 135 crores, during the same period. 

The India Branded Business recorded a 9 percent growth, reaching a topline of Rs. 572 crores for Q1 FY25. Currently, Alembic Pharma holds a 1.3 percent market share of the Indian pharmaceutical market. 

For FY25, the company aims to improve depth in the current strength by new launches planned in FY25 and leveraging launches from FY24. It also plans to upgrade the data-platform by deploying SNOWFLAKE for real-time big data analytics and invest in a new facility to support business growth. 

In addition, Alembic Pharma plans to expand its presence in the MENA (Middle East and North Africa) region. This includes initiating operations in multiple countries and expanding its product portfolio with a dossier extension of non-OSD products across the regions. 

Stock Performance: 

The shares of Alembic Pharma have delivered positive returns of nearly 48.7 percent in one year and around 6.5 percent in the last six months. So far in 2024, it has given about 45.7 percent of positive returns. 

About the company: 

Alembic Pharmaceuticals Limited, a vertically integrated research and development (R&D) pharmaceutical company, is engaged in the business of development, manufacturing, and marketing of pharmaceutical products i.e. Formulations and Active Pharmaceutical Ingredients (APIs). 

Written by Shivani Singh 

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